Viral Vector

AGC Biologics develops and manufactures Lenti and Retro viral vectors. Our ready-to-use platform capabilities are built on cell factories (up to 48L) and bioreactors (up to 200L) using adherent processes, designed entirely in-house. Our quality systems, GMP manufacturing scale and regulatory qualification allow us to meet both clinical and commercial demand. Moreover, our scale down capabilities provide flexible and cost-effective solutions for process development and pre-clinical studies. Since we perform more than 100 analytical tests in-house, AGC Biologics reduces overall turnaround time. With experience manufacturing three commercial products, we are the only Cell & Gene Therapy (C&GT) CDMO that has brought its own product to the market (Zalmoxis^®).

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Tech Transfer & Process Development

Knowledge transfer from client to AGC Biologics
Feasibility studies for new processes with new reagents and materials
Ready-to-use Lenti viral vector manufacturing platforms with off-the-shelf materials (packaging plasmids, master cell bank)
Transfer of client processes at different development stages from R&D scale to cGMP
Small-scale setting up experiments for production of research and non-clinical batches
Small-scale run to certify the quality of the reagents (plasmid DNA, master cell bank, etc.)
Optimization studies to improve process performance
Pilot run to set and define the production methods
LPC and characterization studies
Comparability studies
Analytical development for potency and client specific assays
Qualification of product specific analytical methods before final transfer to QC
Implementation and optimization of automated assays

Up-Stream Process Development

Flexible scale of production in cell factories up to 48L
Flexible scale of production in bioreactors up to 200L
Single-use technologies
Extensive experience of developing in-house and optimizing client processes

Production Scale
- Petri Dishes
- Cell Factory
- Pall iCELLis^® Nano system
- Pall iCELLis^® 500 system

Down-Stream Process Development

Separation Chromatography Techniques

Ion exchange
Size exclusion
Affinity
Ligands

Tangential Flow Filtration

Ultrafiltration
Diafiltration

In-House Analytical Methods Development

Potency Assay

Infectious Viral Titer
Physical Viral Titer
Infectivity
Transgene function

Identity and Chemical/Physical Characteristic

Vector Identity
pH
Osmolality

Purity

Residual BSA/HCP/BENZONASE
Lentiviral Proteins
Residual LTA protein
Residual VSV-G/LTA/E1A and Total DNA

Microbiological Control and Safety

Endotoxin
Sterility
Cultural RCL

cGMP Manufacturing & Quality Control

Ready-to-use in-house platform in cell factories up to 48L
Release, IPC, characterization and stability testing
Analytical method transfer
Method validation in accordance with relevant guidelines
Stability studies management (scheduling, testing, documentation and statistical analysis to support shelf life definition)
Characterization studies management
Outsourcing testing management
Raw materials release

Quality Assurance

Support with regards to regulatory submissions (IND, IMPD, BLA, MAA)
Integrated quality systems incorporating US, European, and ICH cGMP requirements
Comprehensive Quality Agreements
Regulatory compliance and validation expertise
History of successful client audits and regulatory inspections
EU cGMP Certification

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